Approvals

Parker Labs Gains CE Mark for UltraDrape Dressing

Parker Laboratories’ UltraDrape barrier and securement dressing was granted the CE Mark for use in ultrasound-guided peripheral intravenous (UGPIV) insertions.

The device addresses challenges that clinicians face when conducting UGPIV insertions, such as cross contamination, long procedure times, increased risk of infection and securement failure from inadequate gel removal. It also eliminates the need for additional dressings, gel and probe covers.

The product allows clinicians to apply ultrasound gel to a removable film layer that keeps the sterile puncture area dry and gel-free.

FDA Clears Eden Spine’s Lumbar Spine Locking Plate

The FDA granted 510(k) approval to Eden Spine’s Sphynx, a thoraco lumbar spine locking plate used for spine instabilities.

The device, which is made titanium, is implanted via the antero-lateral approach and is used to treat instabilities in the thoraco-lumbar regions of the spine.

Sphynx’s indications include spinal fractures, vertebral tumors, secondary instabilities of the thoracic and thoraco-lumbar spine, and other indications requiring an anterior stabilization low profile.

Meccellis Biotech Granted CE Mark for Breast Reconstruction Products

Meccellis Biotech received the CE Mark for its range of biological matrix products used in abdominal wall and breast reconstruction surgery.

The CE Mark for the products was previously withdrawn. The renewal allows its client, Surgical Innovations, to resume selling the Cellis product range.

The CE Mark covers a range of products that are due to be launched in the UK next year.

Quidel’s Lyme Fluorescent Immunoassay Cleared by FDA

Quidel received FDA clearance for its Sofia 2 lyme fluorescent immunoassay, used in conjunction with its fluorescent immunoassay analyzer to detect human IgM and IgG antibodies.

The assay is used to rapidly diagnose Borrelia burgdorferi — lyme disease — from finger-stick whole blood specimens.

The device integrates wireless connectivity with an updated graphical user interface and optic system.

Embolx Earns CE Mark for Sniper Microcatheters

Silicon Valley-based Embolx earned a CE Mark for its next generation Sniper balloon occlusion microcatheters for the treatment of cancerous tumors, enlarged prostate and uterine fibroids.

The microcatheters are available in 110 cm, 130 cm and 150 cm lengths, enabling physicians to access through femoral or radial arterial sites.

The microcatheters increase therapeutic agent delivery to target areas, while protecting surrounding healthy tissues, by controlling pressure to alter blood flow. Advancements in the balloon and tip designs allow larger vessels to be occluded and improve the ability to track inside vessels.

The Sniper devices received 510(k) clearance from the FDA in June.

Cancer Screening Capsule Cleared for Marketing in Israel

Israel’s Ministry of Health granted Check-Cap marketing approval for its C-Scan capsule for colorectal cancer (CRC) screening.

The ingestible capsule, which received the CE Mark in January, gives physicians structural information about the endoluminal surface of the patient’s colon.

The product can be used for screening CRC in patients at average risk for the disease who cannot or do not wish to receive a colonoscopy.